Mesoblast recruits first patients for pilot clinical trials

Dec 6 2005

Australia's adult stem cell company, Mesoblast Limited, today announced that several patients have now been formally recruited for its Pilot Clinical Trials.

Executive Chairman, Mr Michael Spooner, said today he was very pleased with these developments which reflected the maturity of the company’s proprietary adult stem cell technology and successful implementation of its program for rapid commercialisation.

“We have made enormous progress over the past several months in developing the manufacturing, clinical and regulatory protocols necessary to undertake these ground breaking Pilot Clinical Trials,” Mr Spooner said.

Mesoblast will sponsor two separate Pilot Clinical Trials of up to 10 patients each - one for the repair of large bone fractures which is being conducted at The Royal Melbourne Hospital in Victoria and the other for the treatment of cardiovascular disease which is being conducted at The John Hunter Hospital in Newcastle, New South Wales.

The Pilot Clinical Trials will use the patients’ own stem cells which will be isolated and expanded using Mesoblast’s proprietary platform technology.

The purpose of the Trials is to prove up the safety and, potentially, efficacy, in a clinical environment, of the stem cell manufacturing and regulatory protocols that the company has developed. It is important to note that these protocols form the basis for Mesoblast’s forthcoming Phase II Clinical Trials under the regulatory guidance of the United States Food and Drug Administration (FDA).

Mr Spooner said that the company was very much aware of the intense national and international interest surrounding Mesoblast’s pioneering work in regenerative medicine. In order to balance the need to protect the well being and privacy of the patients involved with the company’s obligations to inform the market on the progress of the Trials in totality on a timely and accurate basis, Mesoblast will adhere strictly to a formal Framework For Disclosure.

This Framework For Disclosure, as outlined below, conforms with good clinical practice and will govern much of the information released to the market regarding the commencement and conduct of Mesoblast’s two Pilot Clinical Trials.

While individual patient outcomes are extremely important, it should be noted that specific individual outcomes will not necessarily reflect the overall outcome of the Pilot Trials and definitive conclusions will require trial completions.